Regulatory Affairs Services
- New Drug registrations (Human Drug, biological, biosimilar, Herbals, Health products, Cosmetics, and Food Supplements).
- New Medical Device Registration (MDMA)
- Authorised Representative (AR)
- Regulatory strategy design and implementation.
- Management of mega regulatory projects (Mergers & Acquisitions, licensing, manufacturing, tech transfer, creation of drug dossiers).
- Local serialization, aggregation, and Unique Device Identifier (UDI)
- Life Cycle Management (Variations, renewals, updates, etc).
- Products classification.
- Compliance review and creation of labelling information such as SPCs, leaflets (PIL), labels, IFUs, and artworks.
Consultation
- New access to the Saudi market: best approaches for appointing local distributors, local authorized representatives, and other partners.
- Drug price evaluation and SFDA appeals.
- Representations and Meetings with the authorities.
- Manufacturing and tech transfer.
- Distributor search, In-Licensing, Out-Licensing, and other contracting modules.
- Patent related consultations.
Pharmacovigilance Services
- Full outsource services of Pharmacovigilance activities.
- QPPV services.
- Building PV systems and documentation (PSMF, PSSF, RMP, PSUR/PEBRER, PV SOPs).
- PV literature review in Saudi journals.
- E2C (R2) Compliance with SFDA.
- Pharmacovigilance Audit.
Technical Files Development
- CMC technical writing.
- eCTD compilation.
- Medical Device technical file development
- ISO 13485 compliance.
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Exploratory Consultation
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